Zirconia Crowns for Tooth Decay

Overseen By Jayakumar Jayaraman, MDS, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Bruxism, Special health needs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data is available for zirconia crowns in treating tooth decay?

The safety data for zirconia crowns in treating tooth decay includes several studies and reviews. A systematic review evaluated clinical, child, and parental satisfaction with zirconia crowns in maxillary primary incisors, highlighting their aesthetic benefits and ease of placement. A prospective cohort study assessed the 5-year survival and success of anterior maxillary zirconia-based crowns, although it noted limited studies in this area. A 29-month follow-up study of a pediatric zirconia crown on a deciduous molar reported sustainable functional restoration, good adaptation, gingival health, and minimal wear on opposing teeth. A retrospective cohort study evaluated the marginal integrity, gingival health, and aesthetics of zirconia crowns on primary maxillary anterior teeth over follow-up periods ranging from 6 to over 30 months. These studies collectively suggest that zirconia crowns are a safe and effective option for restoring decayed primary teeth, with positive outcomes in terms of aesthetics and functionality. ^{1 2 3 4 5}

Is the treatment Zirconia crowns a promising treatment for tooth decay in children?

Yes, Zirconia crowns are a promising treatment for tooth decay in children. They offer a natural appearance, are easy to place, and have shown good retention and aesthetic results over time. They are a practical and effective alternative for restoring decayed primary teeth, addressing both functional and aesthetic needs. ^{1 4 6 7 8}

What data supports the idea that Zirconia Crowns for Tooth Decay is an effective treatment?

The available research shows that Zirconia Crowns are effective for treating tooth decay in children. They are praised for their aesthetic appeal, which is important for both children and parents. One study followed a child with a zirconia crown for 29 months and found that it provided a natural look and maintained good gum health. Another study reported that zirconia crowns stayed in place well and looked good over a 30-month period. These crowns are also easier to place compared to other options, making them a practical choice for restoring decayed teeth. Overall, zirconia crowns are a promising alternative for treating decayed primary teeth, offering both functional and aesthetic benefits. ^{1 3 4 6 7}

Who Is on the Research Team?

Jayakumar Jayaraman, MDS, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with tooth decay who need crowns on their front teeth. The study is testing two types of zirconia-based crowns: one with retention grooves and one without. Specific eligibility details are not provided, so it's best to contact the researchers for more information.

Inclusion Criteria

I have been treated under general anesthesia.

My child is healthy and between 2 to 6 years old.

I have tooth decay that started in early childhood.

Exclusion Criteria

I have worn down or missing opposing teeth.

Teeth that have been subjected to trauma

My teeth are about to fall out.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zirconia-based primary anterior crowns with or without retention grooves

3 months

1 visit (in-person)

Follow-up

Participants are monitored for clinical and radiographic outcomes, as well as parental and child satisfaction

36 months

Multiple visits at 3, 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Zirconia-based primary anterior crowns without retention grooves
• Zirconia-based primary anterior crowns with retention grooves

Trial Overview The effectiveness of two different designs of zirconia-based crowns for front teeth is being compared. One design includes retention grooves that may help hold the crown in place, while the other does not have these grooves.

How Is the Trial Designed?

Group I: Zirconia-based primary anterior crowns without retention grooves Experimental Treatment 1 Intervention

Participants will receive zirconia-based primary anterior crowns without retention grooves

Group II: Zirconia-based primary anterior crowns with retention grooves Experimental Treatment 1 Intervention

Participants will receive zirconia-based primary anterior crowns with retention grooves

Zirconia-based primary anterior crowns without retention grooves is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Approved in United States as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Approved in Canada as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Zirconia crowns are a highly satisfactory treatment option for decayed primary anterior teeth, with both parents and children reporting high levels of satisfaction based on a review of nine studies.

The studies indicate that zirconia crowns provide clinically acceptable restorations for maxillary primary incisors, but future research should involve larger sample sizes and longer follow-up periods to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. Hamrah, MH., Mokhtari, S., Hosseini, Z., et al.[2022]

A zirconia crown was successfully used to restore a primary molar in an 8-year-old boy, demonstrating effective long-term functionality and aesthetics over a follow-up period of 29 months.

The study highlights the importance of proper implementation and maintenance protocols for zirconia crowns, showing that they can maintain gingival health and minimize wear on opposing teeth while providing a natural appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-nine-month follow-up of a paediatric zirconia dental crown. Lopez Cazaux, S., Hyon, I., Prud'homme, T., et al.[2020]

Zirconia crowns provide an effective and aesthetically pleasing solution for restoring extensively decayed primary maxillary anterior teeth in young children, as demonstrated in a case study over a 30-month period.

The crowns showed good retention and functional results after endodontic treatment, making them a practical choice for pediatric dentists dealing with significant tooth structure loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. Ashima, G., Sarabjot, KB., Gauba, K., et al.[2022]

Zirconia crowns are more effective than other types of crowns for restoring primary teeth in children, showing better results in terms of gingival health, aesthetics, and resistance to fractures based on a systematic review of 24 relevant studies.

However, the use of zirconia crowns may lead to increased tooth preparation and wear on opposing teeth, indicating a need for careful consideration in their application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Restorative Full Crowns Made with Zirconia in Children: A Systematic Review. Ajayakumar, LP., Chowdhary, N., Reddy, VR., et al.[2022]

In a study involving 18 participants and 20 zirconia-based anterior maxillary crowns, all crowns showed excellent durability with no fractures or chipping after an average follow-up of 58.7 months.

Participants reported high satisfaction with their crowns (average score of 9.8 out of 10), and there were no instances of proximal caries or periapical pathoses detected over the 5-year period, indicating strong clinical performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort clinical study assessing the 5-year survival and success of anterior maxillary zirconia-based crowns with customized zirconia copings. Dogan, S., Raigrodski, AJ., Zhang, H., et al.[2018]

In a study involving 20 children aged three to five, parents showed a preference for prefabricated primary anterior zirconia crowns over strip crowns, particularly valuing the longevity of the zirconia crowns.

Both types of crowns received positive feedback, but parents noted a significant correlation between their overall satisfaction and the longevity and color of the restorations, with zirconia crowns performing better in terms of longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Parental Satisfaction with Various Aesthetic Crowns Among Children of Various Age Groups: An Original Research. Verma, RK., Srilatha, V., Patel, S., et al.[2023]

Zirconia crowns (ZC) placed on primary maxillary anterior teeth showed good marginal integrity in 82.4% of cases and satisfactory aesthetics, making them a viable treatment option for carious teeth in children.

The study found that crowns placed under general anesthesia had better marginal integrity and periodontal health compared to those placed under sedation, and pulpotomized teeth had poorer color matching with adjacent teeth, indicating the importance of treatment conditions on outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia crown performance in primary maxillary anterior teeth: a retrospective photographic and radiographic cohort study. Yanover, L., Tickotsky, N., Waggoner, W., et al.[2022]

Aesthetic zirconia crowns (ZCs) show adequate properties for restoring decayed primary teeth, including good mechanical resistance and a natural appearance, but there is limited clinical evidence supporting their use compared to stainless steel crowns (SSCs).

Despite the aesthetic advantages of ZCs, stainless steel crowns remain the gold standard for primary teeth restoration, highlighting the need for further research to evaluate the efficacy of ZCs in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia vs. stainless steel pediatric crowns: a literature review. Ludovichetti, FS., Stellini, E., Signoriello, AG., et al.[2021]

Citations

1. Egypt pubmed.ncbi.nlm.nih.gov

Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Twenty-nine-month follow-up of a paediatric zirconia dental crown. [2020]

3. Singapore pubmed.ncbi.nlm.nih.gov

Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Use of Restorative Full Crowns Made with Zirconia in Children: A Systematic Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective cohort clinical study assessing the 5-year survival and success of anterior maxillary zirconia-based crowns with customized zirconia copings. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Assessment of Parental Satisfaction with Various Aesthetic Crowns Among Children of Various Age Groups: An Original Research. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Zirconia crown performance in primary maxillary anterior teeth: a retrospective photographic and radiographic cohort study. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Zirconia vs. stainless steel pediatric crowns: a literature review. [2021]